INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION

NCT06712498 | Completed

• 1 other identifier: mazlum
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale

  They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome

  Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

• Visual Analogue Scale

  The Visual Analogue Scale (VAS) is a subjective measure of pain. It consists of a 10cm line with two endpoints representing 'no pain' and 'worst pain imaginable'. Patients are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.

  Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

Secondary Outcomes (6)

• Riker Sedation Agitation Scale

  Immediately after extubation

• Patient satisfaction score

  at the 24th postoperative hour

• Postoperative vomiting and nausea

  Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

• Opioid use

  Postoperative 24 hours

• Mean Arter Pressure

  when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours

Study Arms (2)

External oblique intercostal plan block group

After endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).

Procedure: External Oblique Intercostal Plane Block

control group

No Intervention

Drug: control group

Interventions

External Oblique Intercostal Plane Block PROCEDURE

After endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).

External oblique intercostal plan block group

control group DRUG

No intervention

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

operating

You may qualify if:

• Patients aged between 18-65
• and with ASA1-2 were included.

You may not qualify if:

• Patients allergic to local anesthetics
• Patients with opioid and alcohol addiction
• Patients with perioperative signs of acute cholecystitis
• Patients with contraindications for laparoscopic surgery
• Cases with ASA III-IV were not included in the study.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation spesialist

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: November 26, 2024
• Primary Completion: December 26, 2024
• Study Completion: December 30, 2024
• Last Updated: November 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)